“may assume her tumor is growing”
——————————————————————
The issue with citing these 3 studies is that each then needs to be reviewed to determine if they have any relevance to the patientsBurzynski has treated in the phase II clinical trials:
——————————————————————[1] – 12/2009 – Pseudoprogression and pseudoresponse in the treatment of gliomas
——————————————————————1. Has Burzynskitreated patients with gliomas, brain tumours, or recurrent glioblastoma ?
——————————————————————2. Has Burzynski’spatients been treated with combined chemo-irradiation with temozolomide which may induce in 20-30% ?
——————————————————————[2] – 5/2008 – Clinical features, mechanisms, and management of pseudoprogression in malignant gliomas
——————————————————————1. Has Burzynskitreated patients with glioblastoma ?
——————————————————————2. Have any of Burzynski’spatients been treated with temozolomide chemoradiotherapy ?
——————————————————————3. so-called pseudoprogression can occur in up to 20% of patients
——————————————————————4. can explain about 1/2 of 20%
——————————————————————[3] – In support of this “phenomenon”, the article provides a link to a Canadian web-site whichposits:
——————————————————————“RT/TMZ is now widely practiced and the standard of care for appropriately selected patients, we are learning more about the consequences of RT/TMZ”

“One phenomena, termed Pseudo-Progression (psPD)…”
——————————————————————
The problem is that this only applies to “Glioblastoma Multiforme (GBM)”, and the article provides NO proof whatsoever, that any of Burzynski’s “Glioblastoma Multiforme (GBM)” patients have taken “RT/TMZ”
——————————————————————
Additionally, the sitecites the reference as:

(“In press” refers to journal articles which have been accepted for publication, but have not yet been published)

However, the journal article in question was published 1/2010, so it has NOT been “in press” for over 3 years and 7 months [4]
——————————————————————GorskGeek stupidly suppositories:
——————————————————————“It’s very heartening to see a story like this in a major news outlet, and I must congratulate Ms. Szabo for her thorough deconstruction of the phenomenon that is Stanislaw Burzynski“
——————————————————————GorskGeek, just because a great portion of Liz Szabo’sUSA TODAYarticlequoted verbatim from The Skeptics™ play book, doesNOT mean she was anymore successful at “deconstructing” Burzynski [5], anymore than you have NOT
——————————————————————GorskGeek then regurgitates:
——————————————————————“Remember how I said that Bob Blaskiewicz will want your help?”

I gave Liz Szabo and USA TODAY the chance to act like a Spike Lee joint and “Do the Right Thing”, the same day their article came out [1]

I gave them the opportunity to prove that their article was a legitimate piece of journalism with some semblance of integrity, and NOT just akin to one of “The Skeptics™ phoned-in “rubber-stamped” yellow journalism hit pieces

Instead, it seems that Liz Szabo and / or USA TODAY decided to act as if they had rolled a Spike Lee joint

I sent an e-mail with 2 editorial corrections, and only one (correcting Lisa Merritt’s commentlink from taking the reader to the 1999 Mayo Clinic report instead of to her comments), was corrected [2]

The 2nd correction which they #FAILED to do, earns them well deserved INSOLENCE
——————————————————————
The articleclaims:
——————————————————————“Burzynski, 70, calls his drugs “antineoplastons” and says he has given them to more than 8,000 patients since 1977.”
——————————————————————

——————————————————————
However, if you select the “8,000 patients” link, the referenced page does NOT indicate that at all [2]
——————————————————————

——————————————————————It advises:
——————————————————————“That same year, Dr. Burzynski founded his clinic in Houston where he’s since treated over 8,000 patients.”[3]
——————————————————————

——————————————————————Nowhere does it indicate that he “treated 8,000 patients” with antineoplastons
——————————————————————

——————————————————————
The question that Liz Szabo and USA TODAY should answer, is:

1. Who is your “fact-checker”, and2. are they smarter than a 5th grader ?
——————————————————————
In fact, Burzynski’s 2002 Securities and Exchange Commission (SEC) filing advises:

” … in 1997, his medical practice was expanded to include traditional cancer treatment options such as chemotherapy, gene targeted therapy, immunotherapy and hormonal therapy in response to FDA requirements that cancer patients utilize more traditional cancer treatment options in order to be eligible to participate in the Company’s Antineoplaston clinical trials”[4]
——————————————————————
The article continues:
——————————————————————“Individual success stories can be misleading, said Arthur Caplan, a professor and head of the division of bioethics at NYU Langone Medical Center”
——————————————————————
The question Arthur Caplan should be asking is:

Why has the United States Food and Drug Administration required Burzynski’s clinical trial patients to fail conventional therapies; such as surgery, chemotherapy, and radiation, BEFORE they are allowed to be treated with antineoplaston therapy ?

If the F.D.A. did NOT impose these restrictions upon Burzynski’s clinical trials, then the question Arthur Caplan raises would be moot
——————————————————————
The article quotes Dr. Jan Buckner as saying:
——————————————————————“When I hear a story that is way out of the norm, the first question I ask is,

‘OK, is the diagnosis even correct?‘ ”

“Buckner said”

“If the diagnosis wasn’t right to start with, it doesn’t matter what the treatment was.”

“Brain tumors are notoriously difficult to diagnose, Buckner says”

“When dealing with rare brain cancer, doctors may disagree about how to interpret imaging results up to 40% of the time”
——————————————————————
I wonder if Dr. Jan Buckner would agree with David Gorski; who is a BREAST cancer oncology specialist, and NOT a BRAIN cancer oncology specialist, who has the presumptiveness to speculate that 3 different medical opinions could have misdiagnosed Tori Moreno in August 1998; who was diagnosed with a very large tumor, about 3 inches in the largest diameter and located in the brain stem, which was too risky for surgery, and about which her parents were told by ALL 3, that Tori’s brain cancer was fatal and, she would die in a few days or at the most, 2-6 weeks, and that there was nothing that could be done, and was finally put on Burzynski’s antineoplaston therapy in October, when she was about 3 ½ months old, and in such condition that they were afraid that she might die at any time, David H. Gorski, M.D., Ph.D., FACS; who claims, “I do know cancer science”, has the audacity, because of his “book learnin'” has the temerity to postulate his “science-based medicine theory” that Miller’s Children at Long Beach Memorial misdiagnosed Tori Moreno’s inoperable stage 4 BSG

David Gorski has the gall to profer that City of Hope misdiagnosed Tori Moreno’s inoperable stage 4 brain stem glioma

David Gorski has the chutzpah to pontificate that Dr. Fred Epstein in New York misdiagnosed Tori Moreno’s inoperable stage IV brainstem glioma [5]
——————————————————————
The article then quotes Peter Adamson, chair of the Children’s Oncology Group:
——————————————————————“But these therapies may have delayed benefits, taking weeks or months to shrink a tumor“

“So patients treated by Burzynski may credit him for their progress, just because he was the last doctor to treat them, says Peter Adamson, chair of the Children’s Oncology Group, an NCI-supported research network that conducts clinical trials in pediatric cancer“

“Conventional cancer treatment can also cause tumors to swell temporarily, due to inflammation“

“A patient who isn’t familiar with this phenomenon may assume her tumor is growing“

“When that swelling subsides, patients may assume it’s because of Burzynski, Adamson says”
——————————————————————
This is laughable

In support of this “phenomenon”, the article provides a link to a Canadian web-site [6]

The site posits:
——————————————————————“RT/TMZ is now widely practiced and the standard of care for appropriately selected patients, we are learning more about the consequences of RT/TMZ”

“One phenomena, termed Pseudo-Progression (psPD)…”
——————————————————————
The problem is that this only applies to “Glioblastoma Multiforme (GBM)”, and the article provides NO proof whatsoever, that any of Burzynski’s “Glioblastoma Multiforme (GBM)” patients have taken “RT/TMZ”
——————————————————————
Additionally, the site cites the reference as:

“The FDA has not yet issued final conclusions”
——————————————————————
The article posts this ridiculous claim:
——————————————————————“Yet the National Cancer Institute says there is no evidence that Burzynski has cured a single patient, or even helped one live longer“
——————————————————————
That’s NOT what this seems to suggest [8]
——————————————————————
Then the article quotes pediatric oncologist Peter Adamson, a professor of pediatrics and pharmacology at Children’s Hospital of Philadelphia, in what will no doubt soon be known as a “classic”:
——————————————————————“He’s a snake oil salesman,” says pediatric oncologist Peter Adamson, a professor of pediatrics and pharmacology at Children’s Hospital of Philadelphia”
——————————————————————
All I’d like to know is, which rock did this clown crawl out from under ?

Dr. Adamson, please advise which “snake oil” has been granted Orphan Drug Designation (“ODD”) from the United States Food and Drug Administration [9], and which “snake oil” has been approved for, and used in, phase III clinical trials ? [10]
——————————————————————Q: Is it, it the phase 2 trial is finished ?

A:“Mhmm”

Q: but they’re still accepting people ?

A:“Yeah”

Q: on more like a special ?

A:“Special basis, and, um, sometimes compassionate grounds“

A:“(compassion exception)”

A:“Uh, exceptions“

Q: That’s normal ?

A:“Yes”“So”

A:“(Yes I guess it is a funding issue ?)”

Q: Right

A:“(Like FDA, during the 2nd phase of clinical trials they found the data to be, real, real one, and they gave him the ok to go for 3rd phase of clinical trials, but just to go through this process you would probably need $100,000)”
——————————————————————

——————————————————————
Oh, wait !!

Dr. Adamson, when you say “snake oil”, I take it you are referring to the low-dose chemotherapy that Burzynski uses ?

Dr. Adamson, do you know what a “hack” is ?
——————————————————————
In regards to the Merritt’s, the article has:
——————————————————————“The couple say that Burzynski misled them about the type of treatment that would be offered, as well as the cost”

My questions about the Merritt’s are:

1. Where is their complaint to the Texas Medical Board ?

2. Where is their lawsuit ? Couldn’t they find an attorney to take their case pro bono ?
——————————————————————
The article continues:
——————————————————————“Yet even Jaffe has acknowledged that the trial — now in its 17th year — was more about politics than science”

“In his 2008 memoirs, Galileo’s Lawyer, Jaffe called it “a joke.””

“”It was all an artifice, a vehicle we and the FDA created to legally give the patients Burzynski’s treatment,” Jaffe said“
——————————————————————
What Liz Szabo and her friends at USA TODAY fail to let the readers know, is that this only applied to one trial:
——————————————————————Burzynski’s lawyer is obviously referring to the CAN-1 clinical trial mentioned in Burzynski’s 11/25/1997 Securities and Exchange Commission (SEC) filing [11]
——————————————————————One trial that is retrospective is CAN-1 Clinical Trial
——————————————————————CAN-1 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH REFRACTORY MALIGNANCIES

133 patients
——————————————————————Clinical trial of patients treated by Dr. Burzynski through 2/23/1996
——————————————————————FDA has indicated it will not accept data generated by this trial since it was not a wholly prospective one
——————————————————————
The article continues in the same vein:
——————————————————————
“In an interview, Burzynski said developing new drugs is complex and takes time”

“Yet the FDA has approved 108 cancer drugs since Burzynski began his trial”
——————————————————————Ms. Szabo and “pals” conveniently “forgets” to educate their audience that Burzynski was using Fleming’s One-sample multiple testing procedure for phase II clinical trials [13], which requires that if the 1st 20 patients meet certain criteria, 20 additional patients are added [14]
——————————————————————“Well, we cannot publish until the time is right” (laughs)

Yeah

“If you would like to publish the results of, of a10 year survival, for instance”

Mmm

“Which we have
Nobody has over 10 year survival inmalignant brain tumor, but we do, and if you like to do it right, it takes time to prepare it, and that’s what we do now
What we publish so far
We publish numerous, uh, publications which were, interim reports when we are still continuing clinical trials
Now we are preparing, a number of publications for final reports“[15]
——————————————————————
Then Fran Visco, president of the National Breast Cancer Coalition makes an outlandish statement, which is quoted in the article:
——————————————————————“Fran Visco, president of the National Breast Cancer Coalition, describes the FDA’s tolerance of Burzynski as “outrageous.””

“They have put people at risk for a long time,” says Visco, an attorney and breast cancer survivor”

“That’s completely unacceptable”

“How can anyone look at these facts and believe that there is a real clinical trial going on … rather than just using the FDA and the clinical trial system to make money?”
——————————————————————
I have a suggestion for Ms. Visco

Take your hypocrisy and ask the American Cancer Society if they are still engaged in this kind of activity:

2.National Cancer Institute and American Cancer Society: Criminal Indifference to Cancer Prevention and Conflicts of Interest [16]
——————————————————————
Then, ask the American Cancer Society, why is it that 10 years ago, estimated breast cancer deaths were expected to be 39,800 (15%), and this year it was 39,620 (14%), which is ONLY 180 LESS than 10 years ago ?
——————————————————————Estimated Breast Cancer Deaths (Women)-USA
——————————————————————2013☝39,620 (14%)
2012👇39,510 (14%)
2011👇39,520 (15%)
2010👇39,840 (15%)
2009👇40,170 (15%)2008☝40,480 (15%)
2007👇40,460 (15%)2006☝40,970 (15%)
2005👇40,410 (15%)2004☝40,110 (15%)
2003☝39,800 (15%)
2002 – 39,600 (15%)
—————————————————————–American Cancer Society Cancer Facts & Figures (2002-2013)
—————————————————————–
And then ask the American Cancer Society, why is it that 10 years ago, the estimated NEW breast cancer cases were expected to be 211,300 (32%), and this year it was 232,340 (29%), which is 21,340 MORE than it was 10 years ago ?
——————————————————————Estimated New Breast Cancer (Women) – USA
——————————————————————2013☝232,340 (29%)
2012👇226,870 (29%)2011☝238,480 (30%)
2010☝207,090 (28%)
2009☝192,370 (27%)
2008☝182,460 (26%)
2007👇178,480 (26%)2006☝212,920 (31%)
2005👇211,240 (32%)2004☝215,900 (32%)
2003☝211,300 (32%)
2002_-_203,500 (31%)
—————————————————————–American Cancer Society Cancer Facts & Figures (2002-2013)
——————————————————————
And after that, ask Susan G. Komen how much is spent on legal action to protect her brand, compared to how much is spent on breast cancer research and prevention ?
——————————————————————Visco, the breast cancer advocate

“I do NOT know why it took YOU so long.”
——————————————————————
The article continues with:
——————————————————————“Yet hypernatremia is one of antineoplastons’ most common side effects, known to doctors for two decades”
——————————————————————
Yet, “The Skeptics™” refuse to discuss:
——————————————————————2/13/2013 – The frequency, cost, and clinical outcomes of hypernatremia in patients hospitalized to a comprehensive cancer center

Over 3 month period in 2006 re 3,446 patients, most of the hypernatremia (90 %) was acquired during hospital stay [19]

Don’t they have the intelligence a “Professor of Writing” should have ?

[3]
——————————————————————
3/12/2013 – Why did “The Skeptics™” on CPT12 and elsewhere whine about publication when the Declaration of Helsinki

30. addresses publishing human clinical trial data

does NOT indicate WHEN the data should be published, leaving it open to interpretation as to if it should be done piecemeal, or when all trials re a specific drug or drugs are completed after Phase I, II, or III, for example ?

[3]
——————————————————————
Why did “The Skeptics™” on CPT12 and elsewhere rant about scientific peer-reviewed journals and their “Impact Factors” but did NOT know what to do about this ?:

National Cancer Institute
at the National Institutes of Health

Cancer Clinical Trials

15. “The results of clinical trials are OFTEN published in peer-reviewed scientific journals”

[4]
——————————————————————
Blaskiewicz, do you have this many honors / awards ?

20 – HONORS AND AWARDS

LIFETIME ACHIEVEMENT AWARD. March 2012. Dallas /Ft. Worth, TX

The Order of Merit of the President of Poland – Officer’s Cross, October, 2004

Decoration of Polish Medical Association, November, 2001

The Order of Saint Brigida – Grand Cross with Star, November, 2001

The Order of Saint Stanislas – Grand Cross with Star, November, 2000

The Order of Reconciliation – Noember, 2000

The Cross Virtus Nobilitat, June, 1999

The Wisdom Award of Honor, December, 1998

The Medal of the President of City of Lublin, Poland, December, 1998

The Order of Saint Stanislas- Commander’s Cross with Star, December, 1997

The Lady Liberty Award “for engaging in invigorating the Right to be Secure in their Effects by fourteen years of perseverance in practicing his Profession free of interference by a government having no probable cause and in the determined resistance to that interference,” Libertarian Party of Texas, Dallas, TX, July, 1997

The Gold Medal from the American Institute of Polish Culture for outstanding achievements in the field of medicine and discovery of anti-cancer drugs antineoplastons, Miami, FL, February, 1997

Recipient of commendation for Dedicated Service and for Personal Contribution made in the
Advancement of Medical Education, Research and Health Care, Baylor College of Medicine, Houston, TX, April, 1977

Phenylacetylglutaminate (PG) and Phenylacetate (PN) are metabolites of PHENYLBUTYRATE (PB) and are constituents of antineoplaston AS2-1

SODIUM PHENYLBUTYRATE was given an orphan drug designation by the FDA for use as an adjunct to surgery,
radiation therapy, and
chemotherapy
for treatment of individuals with
primary or recurrent malignant glioma

Brainstem glioma carries the worst prognosis of all malignancies of the brain

Most patients with brainstem glioma fail standard radiation therapy and chemotherapy and do not survive longer than 2 years

Treatment is even more challenging when an inoperable tumor is of high-grade pathology (HBSG)
patients with inoperable tumor of high-grade pathology (HBSG) treated with antineoplastons in 4 phase 2 trials

39% – overall survival at 2 years
22% – overall survival at 5 years

17+ years maximum survival for a patient with anaplastic astrocytoma

5+ years for a patient with glioblastoma

39% – Progression-free survival at 6 months

5+ year survival in recurrent diffuse intrinsic glioblastomas and anaplastic astrocytomas of the brainstem in a small group of patients

On this week’s episode of the Virtual Skeptics, I replied to what was learned at the premiere of the new Burzynski movie

The text of my segment follows the episode

This week, the new Burzynski movie premiered in San Luis Obispo, California

We largely knew what was going to be in the movie since a couple of trailers had been released, the patients who appeared had talked about the filming, and there was a sort of credulous review had appeared a few days ahead of time and I believe the director may have mentioned it on a PBS fundraising specual a few days earlier

So we had a pretty good idea of what our proxies should be looking for

We really wanted to see if certain people who had been filmed, like Amelia Saunders or Hannah Bradley appeared and especially what was said about them

We wanted lists of people who appeared, to see if we might be able to put together who said what

Most of these people’s stories are well known, and we doubted there would be anything new

Also our people took down key quotes that struck them as important, like

That the director did not mention this fact seems to me inexcusable, making us look like we are big meanos who hate babies and morality

(He could have mentioned your “Fave,” PZ Myers)

[7]
——————————————————————
This demonization is unfair and at the expense of the truth–if you ever read theotherburzynskipatientgroup blog you know whose side I’m on

P Z who ?

[7]
——————————————————————
If he used the video clip of us that he cited in his letter to my employer, about us bringing a “present” to Burzynski and knowing what it actually was without clarifying it, well, that just speaks to his regard for completeness and accuracy

I don’t think you really wanted P Z’s “present” “clarified”

[7]
——————————————————————
No messiah should need such fudging

It suggests to me that he’s forcing evidence into a pre-existing narrative of persecution

You are so busy tweeting about penises that you do NOT have enough time to “Fact-Check” ?

[7]
——————————————————————You do know FDA required ?

” … in 1997, his medical practice was expanded to include traditional cancer treatment options such as
chemotherapy,
gene targeted therapy,
immunotherapy and
hormonal therapy
in response to FDA requirements that cancer patients utilize more traditional cancer treatment options in order to be eligible to participate in the Company’s
Antineoplaston CLINICAL TRIALShttp://www.sec.gov/Archives/edgar/data/724445/000091205702038660/a2091272z10qsb.txt

[8]
——————————————————————
“That said, however, I do disagree with some of his conclusions”

(You could see that coming a mile away, couldn’t you?)

Getler starts off:

[ ” … It is about the decades-long struggle of a Polish-born physician and biochemist, Stanislaw Burzynski, who set up a clinic in Texas in 1976, to achieve acceptance for a cancer-cure therapy based on a treatment he developed based on what he calls “Antineoplastons.” [ANP]”

“I submit this is already wrong
There is little evidence that Burzynski is at all serious about developing antineoplastons for wider marketing”

THAT certainly explains the Phase III stuff

[8]
——————————————————————
“If that were true, surely he would have managed to have completed and published a single advanced trial in 35 years

Bob, who was ultimately in charge of the trials?

The FDA ?

[8]
——————————————————————
“If you look at the trials he’s been required to register at clinicaltrials.gov, you see over 60 trials, 1 completed, and none published

NONE”

Bobby, where is the
Citation(s),
Reference(s), and / or
Link(s)

that support your
“required to register”
statement ?

NONE ?

Are you a sociopath who thinks that people should believe you just because you blogged or twitted it ?

[8]
——————————————————————
“This is important because he is restricted to giving his ANP in clinical trials

But he apparently abandons his trials, almost all of them

This is not normal”

Bobby, how many is
“almost all of them” ?

[8]
——————————————————————
“He charges patients out the nose to participate in the clinical trials

This is not normal”

Does it cost as much as any of THESE ?

Cost cancer: The hospital wanted a $30,000 deposithttp://articles.cnn.com/2009-06-16/politics/health.care.hearing_1_health-insurance-post-claims-underwriting-individual-health?_s=PM:POLITICS2008 – Cost cancer insurance: Avastin, made by Genentech, is a wonder drug. Approved for patients with advanced lung, colon or breast cancer, it cuts off tumors’ blood supply, an idea that has tantalized science for decades. And despite its price, which can reach $100,000 a year, Avastin has become one of the most popular cancer drugs in the world, with sales last year of about $3.5 billion, $2.3 billion of that in the United States. Avastin costs $50,000 a year and adds four months of life. “There is a shocking disparity between value and price,” he said, “and it’s not sustainable.”http://www.nytimes.com/2008/07/06/health/06avastin.html?_r=0Cost cancer chemo up-front: $45,000 to Come Inhttp://online.wsj.com/public/article/SB120934207044648511.html?mod=2_1566_topbox#articleTabs%3Darticle3/2012 – Total Cost of Cancer Care by Site of Service: Physician Office vs Outpatient Hospital (22 pages)http://www.avalerehealth.net/news/2012-04-03_COA/Cost_of_Care.pdfCHEMOTHERAPY:
9/24/2012 – The newspapers found hospitals are routinely marking up prices on cancer drugs by two to 10 times over cost. Some markups are far higher. • Levine Cancer Institute, owned by Charlotte-based Carolinas HealthCare, this year collected nearly $4,500 for a 240-milligram dose of irinotecan, a drug used to treat people with colon or rectal cancer. The average sales price for that amount of the drug: less than $60.
• Carolinas Medical Center-NorthEast in Concord was paid about $19,000 for a one-gram dose of rituximab, used to treat lymphoma and leukemia. That was roughly three times the average sales price.
• Forsyth Medical Center in Winston-Salem, owned by Novant Health, collected about $680 for 50 milligrams of cisplatin. The markup: more than 50 times the average sales price. Treating a cancer patient with Avastin, for instance, costs about $90,000 a year, doctors sayhttp://www.charlotteobserver.com/2012/09/24/3549634/prices-soar-as-hospitals-dominate.html5/14/2012 – Oral anti-cancer medications, on the other hand, are generally considered a pharmacy benefit. Instead of a co-payment, plan members often pay a percentage of the drugs’ cost — up to 50 percent, in some cases — with no annual out-of-pocket limit. And these drugs are expensive, often costing tens of thousands of dollars a year.http://articles.washingtonpost.com/2012-05-14/national/35457286_1_lung-cancer-drug-drugs-work-multiple-myeloma-patientsRADIATION:
1/4/2013 – The new study was the most comprehensive cost analysis ever, and it compared the costs and outcomes associated with the various types of treatment for all forms of the disease, which ranged from $19,901 for robot-assisted prostatectomy to treat low-risk disease, to $50,276 for combined radiation therapy for high-risk disease.http://www.ucsf.edu/news/2013/01/13370/how-prostate-cancer-therapies-compare-cost-and-effectiveness3/15/2012 – Using Surveillance, Epidemiology and End Results (SEER)-Medicare data, the researchers looked at 26,163 women with localized breast cancer who had undergone surgery and radiation from 2001 to 2005. They found that Medicare billing for IMRT increased from 0.9% of patients diagnosed in 2001 to 11.2% of women whose breast cancer was diagnosed in 2005.
The average cost for radiation treatment during the first year was $7,179 for non-IMRT and $15,230 with IMRT. Moreover, billing for IMRT was more than five times higher in regions across the nation where the local Medicare coverage determinations were favorable to IMRT compared to regions where coverage was unfavorable. sorafenib (Nexavar) in kidney cancer as an example. “NICE evaluated sorafenib as it was indicated for kidney cancer and determined that it indeed had value, but not $80,000 per year’s worth. The agency said that it would reimburse one-third of the total cost, and if the drug company wants to market their product to 60 million British citizens, they will need to be price flexible,”http://www.ascopost.com/issues/march-15-2012/rising-costs-in-radiation-oncology-linked-to-medicare-coverage.aspx

[8]
——————————————————————
“I put the word “documentary” in quotes above because while the actual film does indeed document very well Burzynski’s seemingly endless battle to win acceptance and approval for his treatment against the FDA, National Cancer Institute, patent challenges and big pharmaceutical companies — and includes very powerful filmed interviews with cancer survivors who say his treatment (in Texas, where it was allowed) saved them — it doesn’t have the kind of critical other-side that one is used to in other documentaries

That last part is true
the movie is one-sided”

Bobby, you do know that Eric Merola offered oncologist and self-described researcher, David H. Gorski

the opportunity to appear in
Burzynski: Cancer is Serious Business, Part II, and he REFUSED, right ?

[8]
——————————————————————
“Of course, why this is might be more apparent if Mr. Getler had realized that Merola’s cousin was a patient of Burzynski (she later died, of course) and that Merola raised funds for his cousin’s treatments on his website

Merola is not impartial

He has skin in the game

He has sunk an enormous amount into Burzynski”

Yeah, just like every other documentary film-maker or director of multiple movies re the same subject (Jaws, Terminator, Predator, Alien, etc.)

[8]
——————————————————————
“Mr. Getler mentions that Shari Bernson, the person responsible for the programming and who appeared in fundraising spots, described the movie as “controversial.”

To someone on the outside, it may appear to be controversial

To someone who understands the science and process of publication and who has found endless descriptions of how patients end up making really, really bad choices out of desperation at that clinic, however, there is no controversy”

The “controversy” is “The Skeptics” who do NOT know how to “Fact-Check,” and instead “Insert Foot in Mouth”

[8]
——————————————————————
“The fact remains that after 35+ years, the Clinic has never produced a single reproducible result that would constitute the barest minimum for serious consideration among experts

It just hasn’t”

That certainly explains the antineoplaston studies done in Poland, South Korea, Russia, Egypt, Japan, China, Taiwan (ROC), and the USA

“The IRB [Institutional Review Board] used an expedited review procedure for research which did not appear in an FDA list of categories eligible for expedited review, and which had not previously been approved by the IRB”

“Specifically, your IRB routinely provided expedited approvals for new subjects to enroll under Single Patient Protocols.”

“[2 adults and 3 pediatric patients are mentioned]”

“The IRB approved the conduct of research, but did not determine that the risks to subjects were reasonable in relation to the anticipated benefits (if any) to subjects, and to the importance of the knowledge that might be expected to result”

“Specifically, your IRB gave Expedited Approval for several Single Patient Protocols (SPP) without all the information necessary to determine that the risk to subjects are minimized.”

“[4 examples follow]”

“The IRB did not determine at the time of initial review that a study was in compliance with 21 CFR Part 50 Subpart D, ‘Additional Safeguards for Children in Clinical Investigations.’”

“Specifically, an IRB that reviews and approves research involving children is required to make a finding that the study is in compliance with 21 CFR Part 50 Subpart D, ‘Additional Safeguards for Children in Clinical Investigations.’”

“Your IRB approved research involving children without documentation of the IRBs finding that the clinical investigation satisfied the criteria under Subpart D.””

“[3 examples follow and there is a note that this is a repeat observation that had been found in an Oct 2010 Inspection.]”

“The IRB did not follow its written procedure for conducting its initial review of research”

“Specifically, the IRB is required to follow its written procedures for conducting initial and continuing review”

“Your IRB did not follow your written procedures for conducting initial and continuing review because these subjects received IRB approval via an expedited review procedure not described in your Standard Operating Procedures”

“If your IRB would have followed your own SOP for initial and continuing review, the following subjects would have received review and approval from the full board rather than an expedited review.””

“[2 adults and 3 pediatric patients are listed.]”

“The IRB has no written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the FDA of any unanticipated problems involving risks to human subjects or others”

“Specifically, your current SOP-2012 v2-draft doc does not describe the requirements on Investigators on how unanticipated problems are reported to the IRB, Institutional Official, and the FDA, such as time intervals and the mode of reporting, or otherwise address how the prompt reporting of such instances will be ensured.”

“The IRB has no written procedures [in the SOP-2012 v2-draft doc] for ensuring prompt reporting to the IRB, appropriate institutional officials, and the FDA of any instance of serious or continuing noncompliance with theses [sic] regulations or the requirements or determinations of the IRB.”

“A list of IRB members has not been prepared and maintained, identifying members by name, earned degrees, representative capacity, and any employment or other relationship between each member and the institution.”

[8]
——————————————————————
“I’m not sure that this round of investigation is over yet, as the audience at the premier of the sequel was apparently told that the FDA was still on site”

“Researchers should not be playing fast and loose with the rules that protect children (a protected subject population, like prisoners and students–yeah, I’m IRB certified)”

“There should be procedures in place to see that proper oversight and reporting of unexpected events is ensured”

“Hell, there was apparently no document even saying WHO was on the IRB!”

“This is not a report on a serious research institution”

“It’s more like the observations of the IRB of a clown school”

How many more businesses with more IRB issues than Burzynski did you find during you intense “Fact-Finding” mission ?

Bob, did you read Burzynski’s publications with their notes about the IRB ?

“Back to Mr Getler’s letter:”

“On the other hand, Bernson’s sidekick on the in-studio, pledge-drive promotion who was interviewing the clinic spokesman, made me gag when she said,
“I’m Rebecca Stevens and I’m proud to be a journalist who asks the hard questions.”

There were no hard questions”

[I believe the question that followed up this statement was, “What is peer-review?”–RJB]

“And where Bernson may have gone too far, depending on who you believe, was in her statement that:

“Antineoplaston therapy has had significant success rates with terminal brain cancer patients and especially in children.”

No, she went too far no matter who you believe, and his next paragraph demonstrates this:”

“The National Cancer Institute, reporting last month on Antineoplastons, said, among other things:

“No randomized, controlled trials showing the effectiveness of antineoplastons have been published in peer-reviewed scientific journals”
and that they are
“not approved by the U.S. Food and Drug Administration for the prevention or treatment of any disease.”

Aaaand…how’s that controversial?

In light of this, how could Sherri possibly be right?

My bottom line is that CPT12 obviously has a right to show this film

Nobody questions that

“What we wanted, and what was offered to the station, was the opportunity to have an independent oncologist in the studio at the time of the broadcast, you know, to stir up the kind of informed discussion the station says they want to have instead of settling for two True Believers talking to two CPT12 pitch people”

“When the station had that opportunity, they walked away from it”

“That’s indefensible”

Bob, like your man-crush oncologist who refuses to debate ?

[8]
——————————————————————
“Especially when you consider that the people we are worried about, patients and their families, may NOT be as discerning as your average viewer, as CPT President Willard Rowland suggests in his response to the ombudsman:

“The program’s airing is grounded in the station’s mission, specifically those portions about respecting our viewers as inquisitive and discerning citizens, addressing social issues and public concerns not otherwise adequately covered in the community, and cultivating an environment of discovery and learning.”

Some of them haven’t had good news since their diagnosis”

“Then they hear that some lone genius with the cure for cancer is operating in Houston and they are on the next flight down”

“I’ve seen it dozens of times, and I have hundreds more patients on deck to write about”

“These are vulnerable, vulnerable people who deserve the best information from their public broadcasters”

“I’m fairly disappointed by the tepid response, honestly”

“I have a hard time imagining that Mr. Getler, or Mr Willard Rowland for that matter, could possibly think that this program was anything but misleading if they spent a half hour at The OTHER Burzynski Patient Group, which chronicles, in patients’ own words, what goes on in that Clinic”

“All of the people told that getting worse is getting better”

“(for decades being fed the same line!),

the children having strokes

(unrelated to their tumors)

while on the medicine, the “terrifying” amounts of sodium that go into patients”

3) A person with healthy kidneys could develop water intoxication by drinking about 2 to 3 times what their kidneys can process

So, if extremely healthy kidneys could process about 30 ounces per hour and 12 quarts per day would require one to only drink 16 ounces per hour, that means one is being asked to drink 14 ounces less per hour than what extremely healthy kidneys could process

So even if one drinks more than 16 ounces per hour so that one does not have to be awake hourly, there is still opportunity to do that

Of course, there are certain other factors that might have to be taken into consideration depending on the patient

“There are two cases of children (Haley S. and Elizabeth K.) at The OTHER Burzynski Patient Group who have had strokes unrelated to their tumors, likely because of the treatment”

FACT: Is any citation, reference, or link to an independent reliable source provided for this claim?

NO

FACT: Is “STROKE” listed on the above National Cancer Institute (NCI) at the National Institutes of Health (NIH) list as a possible “Adverse Effect”?

[9]
——————————————————————
“This physician and others declined to be interviewed for the movie because of Merola’s track record of slanted presentation and because of past threats issued by people hired by the Burzynski Clinic”

“Past threats issued by people hired by the Burzynski Clinic”?

FACT: Is any citation, reference, or link to an independent reliable source provided for this claim?

[9]
——————————————————————
“What was the “present” from skeptics that was alluded to in the movie?”

“The “present” the Skeptics for the Protection of Cancer Patients (SPCP) delivered to Burzynski on his birthday, was a donation of $14,500 to St Jude Children’s Hospital for research into childhood cancers”

“They challenged Dr. Burzynski to match their donation”

“He did not”

“In fact, some of the interviews in the movie (conducted after the FDA inspection of the Burzynski Clinic, mentioned at the end) were filmed after the fundraiser had been announced, so Merola seems to have deliberately omitted the whole truth, because he certainly was aware of it”

“Merola does not mention that skeptics only caught wind of the Burzynski story in November 2011, after a teenaged blogger critical of the Clinic received phony legal threats from someone who had been hired by the Clinic to “clean up” its reputation”

“This person, Marc Stephens, sent this high school student images of his family’s home, the message clearly:”

“We know where you live.”

“These threats were well documented in the international press”

“Somehow Merola managed to not mention that in the movie”

Maybe it wouldn’t be so bad if the loquacious “teenaged” high school student got his “FACTS” straight:

“Merola suggests that Amelia Saunders died as a result of her parents taking her off of antineoplaston therapy, that there “confusion and disagreement” between the doctors in the UK and Houston’s reading”

[10]
——————————————————————“[T]he emphasis in Phase 2 is on EFFECTIVENESS”

“Phase 3 studies begin if EVIDENCE of EFFECTIVENESS is shown in Phase 2″

[11]
——————————————————————9-10/2009 – Stable disease is a valid end point in clinical trialshttp://www.ncbi.nlm.nih.gov/pubmed/19826356/
strong>10,675 – # of times “stable disease” found on PubMed[12]
——————————————————————costs (see above)

Then United States Food and Drug Administration Commissioner, David Kessler told the American people:

1. We will eliminate unnecessary paperwork … that used to delay or discourage … cancer research … by non-commercial clinical investigators

2. The … FDA’s initiatives … will allow …the agency … to rely on smaller trials … fewer patients … if there is evidence … of partial response in clinical trials
I don’t want to get into any particular … agent … except let me point out … that … the information needs to be part … of clinical trials
3. We will accept … less information … up front –

4. we’re going to require further study AFTER … approval … because the science … has matured

5. The important – point … is that information needs to be gathered … through scientific means … through clinical – trials … and I think – that’s … that’s very important uhh very … important point
You can’t … just … use an agent here – or there … you have to use it … as part of a clinical trial … so we can get information … on whether the drug works

6. The uhh agency has … many … trials … has has approved trials … for patients … with antineoplastons

7. We are committed to providing expanded access … availability … for American patients for any drug … there’s reason to believe … may work
—————————————————————
A. What is the FDA’s definition of “unnecessary paperwork”?

B. What is the FDA’s definition of “smaller trials”?

C. What is the FDA’s definition of “fewer patients”?

D. What is the FDA’s definition of “evidence … of psrtial response”?

E. What is the FDA’s definition of “less information … up front”?

F. What is the FDA’s definition of “we’re going to require further study AFTER … approval”?

G. What is the FDA’s definition of “We are committed to providing expanded access … availability … for American patients for any drug … there’s reason to believe … may work”?

[20]
——————————————————————?
Oncologist

Survival rate 776 15%

2 1/2 million pages

Phase 3 radiation

Lancet

1652 / 335 = 1,799

Accelerated approval

Bob, at least we talked about some of these

[21]
——————————————————————IRB – FDA

Burzynski’s publications sometimes mentioned IRB was agreed on per FDA

[25]
——————————————————————
25. 6/20/2013 Mark Burger published a review:
——————————————————————http://www.yesweekly.com/triad/article-16162-burzynski-cancer-is-.html
——————————————————————
As could be expected, The Skeptics™
showed up
======================================ANONYMOUS:“I’m afraid you’ve fallen for Dr Burzynski’s PR efforts here”
——————————————————————LIE: The documentary film is by Eric Merola, NOT “Dr. Burzynski’s Public Relations”
======================================ANONYMOUS:“In reality, Dr B is a quack and a charlatan of the worst order, and the movie is nothing more than a desperate attempt to try to sell his snake oil to the gullible”
——————————————————————LIE: After reading through the comments, this sounds like the infamous lying Professor Robert J. (Bob) Blaskiewicz of University of Wisconsin, Eau Claire, “infamy”, who is a charlatan of the first order, and belabors his ignorance by referring to “snake oil”, which as far as I know, has never been approved for phase III clinical trials, unlike Dr. Burzynski’s antineoplastons A10 (Atengenal) and AS2-1 (Astugenal)
——————————————————————Bob Blaskiewicz (Blatherskitewicz), Faux Skeptic Exposed!:
——————————————————————https://stanislawrajmundburzynski.wordpress.com/2013/06/07/bob-blaskiewicz-blatherskitewicz-faux-skeptic-exposed/
======================================ANONYMOUS:“You have to ask why he’s never published any data showing that his treatment works”
——————————————————————LIE: What people should ask is why does “Professor” @rjblaskiewicz and his other Skeptic pals continue posting idiotic statements like this on the Internet and social media (Twitter) ?
——————————————————————Critiquing David H. Gorski, MD, PhD, FACShttp://www.sciencebasedmedicine.org/editorial-staff/david-h-gorski-md-phd-managing-editor/
——————————————————————https://stanislawrajmundburzynski.wordpress.com/2013/08/21/critiquing-david-h-gorski-md-phd-facs-www-sciencebasedmedicine-orgeditorial-staffdavid-h-gorski-md-phd-managing-editor/
======================================ANONYMOUS:“Well, if you believe everything the movie tells you, then perhaps you think it’s because of a huge global conspiracy that prevents him from publishing in any journal anywhere in the world”
——————————————————————
If you want to talk Jesse Ventura type “conspiracy theory”:

@PDJudasT @robertquickert Hey, Judas. I have no respect for you as a person. Never address me.
1:56 PM – 18 Mar 2013https://twitter.com/rjblaskiewicz/status/313725494170361856
——————————————————————
On Monday, September 23, 2013, Robert Blaskiewicz wrote:You going to be a rotten little troll or do you want to debate?
——————————————————————You’re the one who posted this on Twitter

Do NOT try to make me the COWARD

Bob Blaskiewicz @rjblaskiewicz

@PDJudasT @robertquickert Hey, Judas. I have no respect for you as a person. Never address me.
1:56 PM – 18 Mar 2013
——————————————————————2/13/2013 (7/2013)
The frequency, cost, and clinical outcomes of HYPERNATREMIA in patients hospitalized to a comprehensive CANCER center

Title: Glioblastoma multiforme: a report of long-term progression-free survival and overall survival of 8 to 16 years after antineoplaston therapy and review of literature

Dear Dr. Burzynski,

Thank you for your recent submission to The Lancet Oncology. We have now had time to consider your manuscript and unfortunately, on this occasion, we have decided not to publish it because we believe the message would be better elsewhere.

Although the decision has not been a positive one, I thank you for your interest in the journal and hope it does not deter from considering us again in the future

At time of approval, NO RESULTS were available from randomized controlled trials in refractory ANAPLASTIC ASTROCYTOMA that show clinical benefit such as improvement in disease-related symptoms or prolonged survivalhttp://clincancerres.aacrjournals.org/content/11/19/6767.full
Was the United States Food and Drug Administration’s 1/1999 accelerated approval based on the PUBLISHED FINAL RESULTS OF A PHASE II (2) CLINICAL TRIAL?

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2764862/Phenylbutyrate is a aromatic fatty acid, able to induce hyperacetylation of histones H3 and H4 and growth arrest, differentiation and apoptosis of AML cell lines and primary leukemic cells. It has been effectively used to induce fetal erythropoiesis in patients with sickle cell anemia and β-thalassemia [105]. The aromatic ring does not contribute to the antitumor activity, as butyric acid is of equal or greater potency at producing these biological changes, while shortening of the fatty acid carbon chain length, as demonstrated with phenylacetate, significantly diminished drug potency [106]. After administration phenylbutyrate is metabolized to phenylacetate, then to phenylacetylglutamine and eliminated by urine [107]. The maximum tolerated doses, when administered as a 7-day continuous infusion, was 375 mg/kg/day, while higher doses were associated with encephalopathy apparently attributable to accumulation of the metabolite phenylacetate. At the maximum tolerated dose (MTD), median steady state concentration of phenylbutyrate is 0.3 mM, which is less than the ED50 of 1-2 mM required for differentiation and cytostasis in vitro but in within the concentration range in which phenylbutyrate
induces acetylation of histones. Dose-limiting toxicities were mainly represented by neurocortical toxicity, including lethargy, confusion, and slurred speech, which completely disappeared within 24 to 48 h upon cessation of the infusion. Non dose-limiting toxicities were hyperammoniemia, hyperuricemia, hypocalcemia, skin abnormalities and interstitial pneumonia [108, 109].
Bobby Blaskiewicz Bows Up ‘Bout Burzynski;https://stanislawrajmundburzynski.wordpress.com/2013/09/24/bobby-blaskiewicz-bows-up-bout-burzynski/

Dr. Friedman asked me to respond to your letter of 3/29/1995 regarding the change we have been considering in eligibility criteria for the Memorial Sloan-Kettering and Mayo Clinic phase II studies of antineoplastons

At the investigator’s request, the amendments to modify the eligibility restrictions for size of tumor, number of tumors, and leptomeningeal spread, and to allow entry of patients with KPS of 60, have been approved

These amendments were initiated by the investigators when it became apparent that many good candidates for the study were being excluded because of what were perceived to be overly stringent and unnecessary eligibility restrictions

Approximately a year ago, we wrote to you asking for your concurrence to make similar changes to the protocol

(see enclosed letter)

We have documented that the revised eligibility criteria are consistent with those used in your very own protocols that employ identical or nearly identical treatment regimens

Furthermore, in a review of the 7 patients in the best case series presented to NCI, we have found that perhaps 4 of the 7 patients who apparently had tumor shrinkage would not have been eligible to enter the NCI phase II studies under the original stringent eligibility criteria

(see attached)

These types of patients will now be eligible for study using the revised eligibility criteria proposed by the investigators and recently approved by CTEP

Despite the difficulties in accrual, we are committed to completing the phase II evaluation of the antineoplastons

Our goals remain unchanged, that is, we wish to determine whether the drugs used in the similar manner as you recommend, and in the similar population of patients, will yield results consistent with those in the best case series

As noted above, our careful evaluation of the materials you have provided indicate that the amendments to the eligibility criteria do not deviate from the eligibility criteria and methods you have employed in your experience

We would appreciate the opportunity to review your data, alluded to in your letter, that support the contention that inclusion of theses patients requires a different treatment regimen or is unsafe

In the meantime, we will allow the amendments to stand, since all evidence you have provided to date indicates that these newly eligible patients may have a chance for benefit without undue risk of harm, and are appropriate candidates for evaluation of the drug

We will forward the data on the 1st 5 patients in a separate mailing as you requested

Pg. 2

However, you have asked that we suspend accrual while you review the data

There is no medical or regulatory reason to suspend accrual at this time

Suspending accrual will likely further damage the efforts the investigators have made to increase accrual to the trial